Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.

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Detailed Description

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Conditions

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Arteriovenous Fistula, Cannulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard cannulation

The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ultrasound guided cannulation

The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula.

Group Type ACTIVE_COMPARATOR